FDA Approves Third Brand of Breast Implant


On March 9, the FDA announced its decision to approve the marketing of a third silicone gel breast implant. This new breast implant is manufactured by Sientra, Inc, and is approved for breast augmentation as well as breast reconstruction. This new silicone gel breast implant is, like the other silicone gel breast implants, approved for placement in women age 22 or older. The breast implants are approved for submuscular or subglandular placement, come in a variety of sizes, and have either smooth or textured shells. As with the other two makes of breast implants, the approval is contingent on the manufacturer conducting post-approval studies that would support the safety and effectiveness of breast implants. For Sientra breast implants, the FDA utilized three years of clinical data from 1788 breast implant patients, data that showed complication rates similar to already-approved breast implants, with the most common complications being asymmetry, capsular contracture, and re-operation. The ongoing activities for Sientra include:

  • Continue monitoring the original 1788 patients for an additional 7 years
  • Conduct a 10-year study of 4782 women to collect information about some of the more common complications of breast implants, including capsular contracture, and possible connections with rheumatoid arthritis and cancer
  • Conduct five case-controlled studies to look at possible links to rare diseases, such as rare connective tissue disorder

At this point, we are unsure whether to offer the new breast implants, but we can help you understand your breast implant options. Please contact plastic surgeon Dr. David A Bottger in Philadelphia today.